NCT02001142

Brief Summary

One of the main objectives of this study will be to assess potential differences in important risk factors associated with Metabolic Syndrome in overweight adults who do not participate in a regular exercise program compared with overweight individuals who do exercise regularly. In addition, we will determine the effects of a single, modest session of exercise on the body's ability to control blood sugar and regulate fat metabolism in obese sedentary adults vs. obese adults who live a physically active lifestyle. Our study focuses on identifying mechanisms responsible for improved insulin action related to regular exercise and to provide novel targets for preventing and treating type 2 diabetes.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
15

participants targeted

Target at below P25 for not_applicable obesity

Timeline
Completed

Started Nov 2013

Typical duration for not_applicable obesity

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2013

Completed
26 days until next milestone

First Submitted

Initial submission to the registry

November 27, 2013

Completed
7 days until next milestone

First Posted

Study publicly available on registry

December 4, 2013

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 17, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 17, 2016

Completed
Last Updated

March 21, 2022

Status Verified

March 1, 2022

Enrollment Period

2.9 years

First QC Date

November 27, 2013

Last Update Submit

March 18, 2022

Conditions

Keywords

Insulin SensitivityExerciseMetabolism

Outcome Measures

Primary Outcomes (1)

  • Insulin Sensitivity

    A hyperinsulinemic-euglycemic clamp will be used to assess peripheral insulin sensitivity. Insulin sensitivity will be calculated from the clamp data as the rate of glucose infusion during the steady state period of the clamp - divided by the plasma insulin concentration at this time (units: mg/uU/ml/min)

    2-3 hours

Secondary Outcomes (2)

  • Resting Metabolic Rate

    20-30 min

  • Meal Tolerance Test

    3 hours

Study Arms (2)

Exercise

EXPERIMENTAL
Other: Exercise

Sedentary Control

NO INTERVENTION

Interventions

single session of exercise

Exercise

Eligibility Criteria

Age18 Years - 40 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Body Mass Index \[BMI\] = 30-45 kg/m2, fasting blood glucose concentration must be \< or = to125 mg/dl, Hematocrit \> or = to 34%, all women must be pre-menopausal

You may not qualify if:

  • pregnancy or actively breastfeeding, weight instability (\> or = to ± 5 lbs in the past month) evidence of cardiovascular or metabolic diseases, taking medications know to affect lipid and/or glucose metabolism.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Michigan Clincal Research Unit

Ann Arbor, Michigan, 48109, United States

Location

MeSH Terms

Conditions

ObesityInsulin ResistanceMotor Activity

Interventions

Exercise

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsHyperinsulinismGlucose Metabolism DisordersMetabolic DiseasesBehavior

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Jeffrey F Horowitz, PhD

    University of Michigan

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor, Movement Science, School of Kinesiology

Study Record Dates

First Submitted

November 27, 2013

First Posted

December 4, 2013

Study Start

November 1, 2013

Primary Completion

September 17, 2016

Study Completion

September 17, 2016

Last Updated

March 21, 2022

Record last verified: 2022-03

Locations